FDA offers warfarin guidelines

August 17, 2007|Associated Press

WASHINGTON -- Federal health officials are stopping short of recommending genetic tests for patients on the blood-thinner warfarin, even though they have said such screenings could prevent thousands of complications each year.

Warfarin, sold under the brand name Coumadin and in generic forms, yesterday became the first widely used drug to include genetic testing information on its label. The information can help doctors determine how best to prescribe the drug.

"This means personalized medicine is no longer an abstract concept but has moved into the mainstream," the Food and Drug Administration's clinical pharmacology chief, Larry Lesko, said in disclosing the label change.

The updated label for warfarin suggests that lower doses may be best for patients with variations in two specific genes.

The FDA has not changed its dosing recommendations for the drug, and tailoring the proper dosage remains largely a matter of trial and error. Patients taking too much warfarin can bleed to death. If people take too little of the drug, it can fail to protect them from deadly blood clots and stroke.

Genetic testing can reveal which patients may require less of the drug and lead doctors to recommend doses closer to the lower end of the scale, FDA officials said.

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